Effect of Using (PEKK) Framework Versus (Co- Cr) Framework on The Bone of Mandibular Implant Supported Hybrid Prostheses

December 17, 2023 updated by: Ain Shams University

Effect of Using Polyetherketoneketone (PEKK) Framework Versus Cobalt Chromium Framework on The Supporting Structures of Mandibular Implant Supported Hybrid Prostheses

the purposse of the study To evaluate the effect of implant supported hybrid prostheses on the bone of the supporting structure of edentulous mandible using Polyetherketoneketone (PEKK) framework versus cobalt chromium framework. fourteen female patients with lower single edentulous ridges are chosen with adequate dental hygiene, enough interarch space and free of systemic diseases and parafunctional habits. Patients who received new single dentures are randomly allocated into each group using computer software program and five intraforaminal implants were inserted parallel using surgical guide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient's approval:

  • All patients will be informed in details about the nature of the investigation and the aim of the study. They will agree to take part in the study and will sign on an informed consent form.
  • All participants will be given notice about their privacy practices, their legal duties and their rights.
  • In case of implant treatment failure, the patients will receive a new well-fitting denture.

Patient's grouping:

In this study there will be two equal groups, grouping will be based on the material that will be used for framework construction:

Group I: framework will be fabricated using PEKK. Group II: frame work will be fabricated using cobalt chromium alloy.

Clinical steps:

Pre-prosthetic phase:-

  • Conventional single lower denture will be made for all patients.
  • Occlusal adjustment of upper teeth will be done for all patients.
  • The single lower denture will be duplicated with radiographic markers and CBCT will be used to determine exact position of implants.

Surgical phase:-

  • Five conventional implants in intraforaminal area will be placed according to the planned cone beam CT using surgical guide to accurately place the implants.
  • Postoperative analgesics and anti-inflammatory medications will be described.
  • After osseointegration, second surgery will be carried out and healing abutment will be screwed for each implant.

Prosthetic phase:-

  • After healing period open top tray impression will be made.
  • Jaw relation record will be taken using record bases and wax rims.
  • Group I: The PEKK framework will be milled using milling machine.
  • Group II: cobalt chromium framework will be made with wax pattern milling then casted by conventional method.
  • The PEKK framework will be veneered with zirconia and the cobalt chromium will be veneered with porcelain.
  • Implant supported fixed detachable prostheses using PEKK framework or cobalt-chromium framework will be screw retained to conventional implants.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dalia Mohammed Farid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient's age range from 50 to 60 year's old.
  • All patients are with completely edentulous mandible.
  • Good oral hygiene is mandatory.
  • Sufficient interarch space to accept implant supported fixed prosthesis will be diagnosed by mounted diagnostic casts.
  • Firm and healthy mucosa covering the alveolar ridge.
  • Minimum bone width 5.5mm buccolinguallly and 10 mm height will be diagnosed by the preoperative cone beam CT scan.

Exclusion Criteria:

  • - Vulnerable group; prisoners, mentally, physically disabled, pregnant females.
  • Patients with Para functional habits.
  • Patients having TMJ disorders.
  • Uncontrolled diabetic patients
  • Patients have any medical condition or any disease that could interfere with implant placement or affect bone loss.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: (PEKK fixed hybrid prostheses
5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow
Procedure: implant placement
5 implant were placed in intraforaminal area using surgical guide
Other Names:
  • final prostheses was made on 5 implants
Other: PFM fixed hybrid prostheses
5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow until making wax pattern the casting was made.
Procedure: implant placement
5 implant were placed in intraforaminal area using surgical guide
Other Names:
  • final prostheses was made on 5 implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of bone loss around implant
Time Frame: 2 years
The points of first bone contact with the fixture platform were detected and changes of those points position through the two years of observation were registered as a criterion of bone changes with further calculation of average values. A software ruler of CBCT was used to measure the crestal bone height in contact with the implant from the four aspects (buccal, lingual, mesial and distal).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: dina essam bahig, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

September 2, 2023

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-RecID032134

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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